ISO 9001:2015 - SD Manufacturing 2015... · The new ISO 9001:2015 The new ISO 9001 2015 standard is...

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ISO 9001:2015 October 5 th , 2017 Brad Fischer www.SDManufacturing.com

Transcript of ISO 9001:2015 - SD Manufacturing 2015... · The new ISO 9001:2015 The new ISO 9001 2015 standard is...

ISO 9001:2015

October 5th, 2017

Brad Fischer

www.SDManufacturing.com

Purpose of presentation

Provide a summary of notable changes from ISO 9001:2008 to ISO 9001:2015

Key perspectives

ISO 9001 needs to change, to:

adapt to a changing world

reflect the increasingly complex environments in which organizations operate

provide a consistent foundation for the future

ensure the new standard reflects the needs of all relevant interested parties

ensure alignment with other management system standards

Key benefits of thecommon clause structure

A new common format has been developed

All ISO management systems standards will look

the same with the same structure (some deviations)

More efficient to address multiple management

system requirements

Provides the option of integrating management

systems

Standardized core definitions

Beneficial changes to ISO 9001

Enhanced leadership involvement in the management system

Risk-based thinking

Simplified language, common structure and terms

Aligning QMS policy and objectives with the strategy of the organization

Potential benefitsto the user

Focus on achieving planned results

Flexibility for documented information

Improved risk control

Better process control leading to improved results

Improved customer satisfaction

Customer retention and loyalty

Improved image and reputation

Greater credibility

Use ISO 9001:2015 if:

You need to be able to show that your organization is consistently capable of providing products and services that meet customer requirements and comply with all relevant statutory and regulatory requirements.

You need to be able to demonstrate that your organization can enhance customer satisfaction because it is consistently capable of continually improving both its products and services and its practices and processes.

You need to be able to assess your organization's ability to consistently provide products and services that meet customer requirements and comply with all relevant statutory and regulatory requirements.

The new ISO 9001:2015

The new ISO 9001 2015 standard is based on seven quality management principles. These principles were chosen because they can be used to enhance corporate performance and to achieve sustained success. They form the conceptual foundation for the ISO portfolio of quality management standards and were used to guide the development of this new standard.

Focus on customers and interested parties

In order to enhance corporate performance and achieve sustained success, organizations must focus on both their customers and their interested parties. Organizations can establish this focus by trying to understand the current and future requirements and expectations of both their customers and their interested parties and by constantly trying to meet these requirements and exceed these expectations.

Provide leadership for your organization

In order to enhance corporate performance and achieve sustained success, organizations must ensure that suitable leadership is provided at all levels. Suitable leadership is provided whenever leaders at all levels establish a unity of purpose and whenever they create an environment that encourages people to pursue a common directionand achieve a common set of objectives. By establishing a common purpose, leaders can ensure that all strategies, policies, processes, and resources are aligned and being used to pursue a common direction and to achieve a common set of objectives.

Engage and involve your people

In order to enhance corporate performance and achieve sustained success, organizations must be able to create and deliver value. In order to do so they must have people who are competent, they must enhance their knowledge and skills, and they must manage them effectively by empowering them, by encouraging their involvement and engagement at all levels, and by recognizing their achievements.

Use a process approach

In order to enhance corporate performance and achieve sustained success, organizations must use a process approach to manage their activities. The process approach is a management strategy. When managers use this approach, it means that they manage and control their processes, the interactions between these processes, and the inputs and outputs that tie these processes together. It also means that they manage these interactions as a system. When this approach is applied to quality management, it means that they manage their processes and their process interactions as a coherent quality management system.

Encourage improvement

In order to enhance corporate performance and achieve sustained success, organizations must encourage and support improvement. If they wish to maintain current levels of performance, if they wish to respond to changing conditions, and if they wish to identify, create, and exploit new opportunities, organizations must establish and sustain an ongoing focus on improvement.

Use evidence to make decisions

In order to enhance corporate performance and achieve sustained success, organizations must establish an evidence-based decision making process. Decision making is evidence-based whenever multiple types of input are gathered from multiple sources, whenever facts are identified, whenever data is analyzed objectively, whenever cause and effect relationships are examined, whenever potential unintended consequences are considered, and whenever all of this is used to make corporate decisions.

Manage your corporate relationships

In order to enhance corporate performance and achieve sustained success, organizations must manage their relationship with suppliers, partners, and other interested parties. Relationships must be carefully managed because suppliers, partners, and other interested parties can influence corporate performance and undermine corporate success.

Structure of the standard

Perhaps the biggest difference between the old and the new standard is the structure. ISO 9001 2008 had five main sections (4 to 8) and ISO 9001 2015 now has seven (4 to 10). This is because the new edition uses the new Annex SL template. According to ISO, all future management system standards (MSSs) will use this new layout and share the same basic requirements.

ISO 9001:2015 to ISO 9001:2008Correlation Matrix

ISO 9001:2015 ISO 9001:2008

1 Scope 1 Scope

1.1 General

4 Context of the organization 4 Quality management system

4.1 Understanding the organization and its context

4 Quality management system

5.6 Management review

4.2 Understanding the needs and expectations of interested parties

4 Quality management system

5.6 Management review

4.3 Determining the scope of the quality management system

1.2 Application

4.2.2 Quality manual

4.4 Quality management system and its processes

4 Quality management system

4.1 General requirements

5 Leadership 5 Management responsibility

5.1 Leadership and commitment 5.1 Management commitment

5.1.1 General 5.1 Management commitment

5.1.2 Customer focus 5.2 Customer focus

5.2 Policy 5.3 Quality policy

5.2.1 Establishing the Quality Policy 5.3 Quality policy

5.2.2 Communicating the Quality Policy 5.3 Quality policy

5.3 Organizational roles, responsibilities and authorities

5.5.1 Responsibility and authority

5.5.2 Management representative

5.4.2 Quality management system planning

6 Planning 5.4.2 Quality management system planning

6.1 Actions to address risks and opportunities 5.4.2 Quality management system planning

8.5.3 Preventive action

6.2 Quality objectives and planning to achieve them

5.4.1 Quality objectives

6.3 Planning of changes 5.4.2 Quality management system planning

ISO 9001:2015 to ISO 9001:2008Correlation Matrix

7 Support 6 Resource management

7.1 Resources 6 Resource management

7.1.1 General 6.1 Provision of resources

7.1.2 People 6.1 Provision of resources

7.1.3 Infrastructure 6.3 Infrastructure

7.1.4 Environment for the operation of processes

6.4 Work environment

7.1.5 Monitoring and measuring resources 7.6 Control of monitoring and measuring equipment

7.1.5.1 General 7.6 Control of monitoring and measuring equipment

7.1.5.2 Measurement traceability 7.6 Control of monitoring and measuring equipment

7.1.6 Organizational knowledge No equivalent clause

7.2 Competence 6.2.1 General

6.2.2 Competence, training and awareness

ISO 9001:2015 to ISO 9001:2008Correlation Matrix

7.3 Awareness 6.2.2 Competence, training and awareness

7.4 Communication 5.5.3 Internal communication

7.5 Documented information 4.2 Documentation requirements

7.5.1 General 4.2.1 General

7.5.2 Creating and updating 4.2.3 Control of documents

4.2.4 Control of records

7.5.3 Control of documented Information 4.2.3 Control of documents

4.2.4 Control of records

ISO 9001:2015 to ISO 9001:2008Correlation Matrix

8 Operation 7 Product realization

8.1 Operational planning and control 7.1 Planning of product realization

8.2 Requirements for products and services

7.2 Customer-related processes

8.2.1 Customer communication 7.2.3 Customer communication

8.2.2 Determination of requirements for products and services

7.2.1 Determination of requirements related to the product

8.2.3 Review of the requirements for products and services

7.2.2 Review of requirements related to the product

8.2.4 Changes to requirements for products and services

7.2.2 Review of requirements related to the product

8.3 Design and development of products and services

7.3Design and development

8.3.1 General 7.3.1 Design and development planning

8.3.2 Design and development planning 7.3.1 Design and development planning

8.3.3 Design and development inputs 7.3.2 Design and development inputs

8.3.4 Design and development controls 7.3.4 Design and development review

7.3.5 Design and development verification

7.3.6 Design and development validation

8.3.5 Design and development outputs 7.3.3 Design and development outputs

8.3.6 Design and development changes 7.3.7 Control of design and development changes

ISO 9001:2015 to ISO 9001:2008Correlation Matrix

8.4 Control of externally provided processes, products and services

7.4.1 Purchasing process

8.4.1 General 4.1 General requirements

7.4.1 Purchasing process

8.4.2 Type and extent of control 7.4.1 Purchasing process

7.4.3 Verification of purchased product

8.4.3 Information for external providers 7.4.2 Purchasing information

7.4.3 Verification of purchased product

8.5 Production and service provision 7.5 Production and service provision

8.5.1 Control of production and service provision

7.5.1 Control of production and service

provision

7.5.2 Validation of processes for production and service provision

8.5.2 Identification and traceability 7.5.3 Identification and traceability

8.5.3 Property belonging to customers or external providers

7.5.4 Customer property

8.5.4 Preservation 7.5.5 Preservation of product

8.5.5 Post-delivery activities 7.5.1 Control of production and service provision

8.5.6 Control of changes 7.3.7 Control of Design and Development Changes

8.6 Release of products and services 7.4.3 Verification of purchased product

8.2.4 Monitoring and measurement of product

8.7 Control of nonconforming outputs 8.3 Control of nonconforming product

ISO 9001:2015 to ISO 9001:2008Correlation Matrix

9 Performance evaluation 8 Measurement, analysis and improvement

9.1 Monitoring, measurement, analysis and evaluation

8 Measurement, analysis and improvement

9.1.1 General 8.1 General

8.2.3 Monitoring and Measurement Processes

9.1.2 Customer satisfaction 8.2.1 Customer satisfaction

9.1.3 Analysis and evaluation 8.4 Analysis of data

9.2 Internal audit 8.2.2 Internal audit

9.3 Management review 5.6 Management review

9.3.1 General 5.6.1 General

9.3.2 Management review input 5.6.2 Review input

9.3.3 Management review output 5.6.3 Review output

10 Improvement 8.5 Improvement

10.1 General 8.5.1 Continual improvement

10.2 Nonconformity and corrective action 8.3 Control of nonconforming product

8.5.2 Corrective action

10.3 Continual Improvement 8.5.1 Continual improvement

8.5.3 Preventive action

Key feature changes

10-clause structure and core text for all Management System

Standards (MSS)

More compatible with services and non-manufacturing users

Clearer understanding of the organization’s context is required

“one size doesn’t fit all”

Process approach strengthened/more explicit

Concept of preventive action now addressed throughout the

standard by risk identification and mitigation

The term documented information replaces the terms document

and record

Control of externally provided products and services replaces

purchasing/outsourcing

Increased emphasis on seeking opportunities for improvement

Context of the organization

Unlike the old standard, the new one expects you to understand your organization's context before you establish its QMS. This means that you need to understand your organization's external environment, its culture, its values, its performance, and its interested parties before you develop its QMS. Why? Because your QMS will need to be able to manage all of these influences.

Use a process approach

In order to enhance corporate performance and achieve sustained success, organizations must use a process approach to manage their activities. When thisapproach is applied to quality management, it means that they manage their processes and their process interactions as a coherent quality management system.

Risk-based thinking

ISO 9001 has always been about anticipating and preventing mistakes, which is what risk-based thinking is all about. That's why we train people, why we plan our work, why we assign roles and responsibilities, why we validate and verify results, why we audit and review activities, and why we monitor, measure, and control processes. We do these things because we want to prevent mistakes. We do them because we're trying to manage risk. So, if we think of risk-based thinking in this way, it's always been an inherent part of ISO 9001. Before it was implicit; now it's explicit.

Documented information

According to ISO's definition, the term documented information refers to information that must be controlled and maintained. So, whenever ISO 9001 2015 uses the term documented information it implicitly expects you to control and maintain that information and its supporting medium. An annex to the new standard (A.6) further says that "Where ISO 9001:2008 would have referred to documented procedures ... this is now expressed as a requirement to maintain documented information”, and "Where ISO 9001:2008 would have referred to records this is now expressed as a requirement to retain documented information".

Documented information

So, whenever the new standard refers to documented information and it asks you to maintain this information, it's talking about what used to be referred to as procedures, and whenever it asks you to retain this information, it's talking about what used to be called records. So sometimes it must be maintained and sometimes it must be retained.

Encourage improvement

In order to enhance corporate performance and achieve sustained success, organizations must encourage and support improvement. If they wish to maintain current levels of performance, if they wish to respond to changing conditions, and if they wish to identify, create, and exploit new opportunities, organizations must establish and sustain an ongoing focus on improvement.

Requirements and exclusions

Section 4.3 of ISO 9001 2015 says “The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system”. However, while the new ISO 9001 2015 standard says that every requirement must be applied, section 4.3 and Annex A5 also says that any requirement may be excluded if it cannot be applied, if you can justify and explain why it can’t be applied, and if excluding it does not undermine your ability or responsibility to ensure that products and services are in compliance.

Structure of ISO 9001:2015

1 Scope 2 Normative references 3 Terms and definitions

4 Context of the organization 4.1 Understanding the organization and its context 4.2 Understanding the needs and expectations of interested

parties4.3 Determining the scope of the quality management system 4.4 Quality management system and its processes

5 Leadership5.1 Leadership and commitment5.2 Policy 5.3 Organizational roles, responsibilities and authorities

6 Planning 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes

Structure of ISO 9001:2015 7 Support

7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information

8 Operation 8.1 Operational planning and control8.2 Requirements for products and services 8.3 Design and development of products and services 8.4 Control of externally provided processes, products and

services8.5 Production and service provision8.6 Release of products and services8.7 Control of nonconforming outputs

Structure of ISO 9001:20159 Performance evaluation

9.1 Monitoring, measurement, analysis and evaluation

9.2 Internal audit

9.3 Management review

10 Improvement

10.1 General

10.2 Nonconformity and corrective action

10.3 Continual improvement

The common structure and ISO 9001:2015 additions

4 Context of organization

5 Leadership 6 Planning 7 Support 8 Operation9 Performance Evaluation

10 Improvement

4.1 Understanding context

4.2 Interested parties

4.3 Scope

4.4 QMS

5.1 Leadership and commitment

6.1 Risks and opportunities

6.2 Planning

7.1 Resources

9.1 Monitoring, measurement, analysis and evaluation

10.1 General

10.3 Continual improvement

7.3 Awareness

7.4 Communication

7.5 Documented information

7.2 Competence 9.2

Internal audit

9.3 Management review

8.1 Operational planning and control

5.2 Policy

5.3 Organizational roles, responsibilities and authorities

10.2 Nonconformity and corrective action

8 Operation

8.1 Operational planning and control

The common structure and ISO 9001:2015 additions

Do Check ActPlan

4 Context of

organization

5 Leadership

6 Planning

8 Operation

9 Performance

and Evaluation

10 Improvement

4.1 Understanding

context

4.2 Interested parties

4.3 Scope

4.4QMS

5.1 Leadership and

commitment

6.1 Actions to

address risks and opportunities

6.2 Quality objectives

and planning

9.1 Monitoring,

measurement, analysis and evaluation

10.2 Nonconformity and corrective

action

10.3Continual

improvement

5.3Organizational

roles, responsibilities and authorities

9.2Internal audit

9.3 Management

review

8.1 Operational

planning and control

5.2 Policy

6.3 Planning of

changes

9.1.2Customer

satisfaction

9.1.3 Analysis and

evaluation

See next slide

7 Support

7.1 Resources

7.3 Awareness

7.4 Communication

7.5 Documented information

7.2 Competence

7.1.4 Environment for the

operation of processes

7.1.5 Monitoring and

measuring resources

7.1.2 People

7.1.3 Infrastructure

7.1.6 Organizational

knowledge

10.1General

Clause 4.1 Determine what the relevant external and internal issues are for your organization, and that are relevant to its strategic direction

4 Context of

organization

4.1 Understanding

context

4.2 Interested parties

4.3 Scope

4.4QMS

Clause 4.2Identify the relevant interested parties and their relevant requirements

4 Context of

organization

4.1 Understanding

context

4.2 Interested parties

4.3 Scope

4.4QMS

Clause 4.3 and 4.4

The requirement for the scope is now better defined, must be documented and consider:

external and internal issues

requirements of relevant interested parties

the products and services covered (must also be stated in scope)

allowing applicability of specific requirements

justification for any case where a requirement cannot be applied (exclusion)

4 Context of

organization

4.1 Understanding

context

4.2 Interested parties

4.3 Scope

4.4QMS

4 Context of

organization

5 Leadership

6 Planning

8 Operation

9 Performance

and Evaluation

10 Improvement

4.1 Understanding

context

4.2 Interested parties

4.3 Scope

4.4QMS

5.1 Leadership and

commitment

6.1 Actions to

address risks and opportunities

6.2 Objectives and

planning

9.1 Monitoring,

measurement, analysis and evaluation

5.3 Organizational

roles, responsibilities and authorities

9.2Internal audit

9.3 Management

review

8.1 Operational

planning and control

5.2 Policy

6.3 Planning of

changes

9.1.2Customer

satisfaction

9.1.3 Analysis and

evaluation

See next slide

7 Support

7.1 Resources

7.3 Awareness

7.4 Communication

7.5 Documented information

7.2 Competence

7.1.4 Environment for the

operation of processes

7.1.5 Monitoring and

measuring resources

7.1.2 People

7.1.3 Infrastructure

7.1.6 Organizational

knowledge

10.2 Nonconformity and corrective

action

10.3Continual

improvement

10.1General

Clause 5.1.1

Leadership is required to ensure:

take accountability for the effectiveness of the quality management system

ensure the quality policy and quality objectives are compatible with the context and strategic direction of the organization

ensure the integration of the QMS requirements into the organization’s business processes

promote the use of the process approach and risk-based thinking

ensure that the QMS achieves its intended results

engage, direct and support persons to contribute to the effectiveness of the QMS

supporting relevant management roles

promotion of improvement

Clause 5.1.2

Top management needs to ensure customer satisfaction through:

customer and applicable statutory and regulatory requirements being determined and met

risk and opportunities are being addressed

the focus on products and services meeting customers and other requirements

5 Leadership

5.1 Leadership and

commitment

5.2Policy

5.3Organizational roles, responsibilities and

authorities

5 Leadership

5.1 Leadership and

commitment

5.3Organizational roles, responsibilities and

authorities

5.2 Policy

Clause 5.2

Explicit requirement to apply the policy

Clause 5.2

Explicit requirement to apply the policy

Clause 5.3

Explicit requirement for relevant roles to be assigned,

communicated and understood

No requirement for a specific management

representative and the responsibility now resides with

top management to assign and manage

Requirement for defining responsibility and authority

for ensuring processes are delivering their intended

outputs

5 Leadership

5.1 Leadership and

commitment

5.2Policy

5.3Organizational roles, responsibilities and

authorities

4 Context of

organization

5 Leadership

6 Planning

8 Operation

9 Performance

and Evaluation

10 Improvement

4.1 Understanding

context

4.2 Interested parties

4.3 Scope

4.4QMS

5.1 Leadership and

commitment

6.1 Actions to

address risks and opportunities

6.2 Quality objectives

and planning

9.1 Monitoring,

measurement, analysis and evaluation

5.3Organizational

roles, responsibilities and authorities

9.2Internal audit

9.3 Management

review

8.1 Operational

planning and control

5.2 Policy

6.3 Planning of

changes

9.1.2Customer

satisfaction

9.1.3 Analysis and

evaluation

See next slide

7 Support

7.1 Resources

7.3 Awareness

7.4 Communication

7.5 Documented information

7.2 Competence

7.1.4 Environment for the

operation of processes

7.1.5 Monitoring and

measuring resources

7.1.2 People

7.1.3 Infrastructure

7.1.6 Organizational

knowledge

10.2 Nonconformity and corrective

action

10.3Continual

improvement

10.1General

Clause 6.1

Considering the issues raised and relevant interested

parties’ requirements identified (4.1 and 4.2), this clause

requires the determination of risks and opportunities

which need to be addressed, actions to be taken and

evaluation of the effectiveness of these actions

6 Planning

6.1 Actions to address risks

and opportunities

6.2 Objectives and planning

6.3 Planning of changes

Clause 6.2

Objectives should be:

established for processes relevant to the QMS

in line with customer requirements

in line with products and services conformity

monitored, communicated & updated

6 Planning

6.1 Actions to address risks

and opportunities

6.2 Objectives and planning

6.3 Planning of changes

Clause 6.3

Changes to the QMS should be carried out in a planned manner

The standard has evolved to enable organizations to adapt to changing environments or circumstances

Note: It is important to know that change is addressed in the following clauses:

Clause 6.3 - Planning/implementing changes to the QMS

Clause 7.1.6 - Organizational knowledge - for addressing changing needs and trends, with respect to knowledge

Clause 8.1 - Controlling operational changes, planned and unintentional

Clause 8.5.6 - Addressing changes affecting products & services

6 Planning

6.1 Actions to address risk

and opportunity

6.2 Objectives and planning

6.3 Planning of changes

4 Context of

organization

5 Leadership

6 Planning

8 Operation

9 Performance

and Evaluation

10 Improvement

4.1 Understanding

context

4.2 Interested parties

4.3 Scope

4.4QMS

5.1 Leadership and

commitment

6.1 Actions to

address risks and opportunities

6.2 Objectives and

planning

9.1 Monitoring,

measurement, analysis and evaluation

5.3 Organizational

roles, responsibilities and authorities

9.2Internal audit

9.3 Management

review

8.1 Operational

planning and control

5.2 Policy

6.3 Planning of

changes

9.1.2Customer

satisfaction

9.1.3 Analysis and

evaluation

See next slide

7 Support

7.1 Resources

7.3 Awareness

7.4 Communication

7.5 Documented information

7.2 Competence

7.1.4 Environment for the

operation of processes

7.1.5 Monitoring and

measuring resources

7.1.2 People

7.1.3 Infrastructure

7.1.6 Organizational

knowledge

10.2 Nonconformity and corrective

action

10.3Continual

improvement

10.1General

7.1 Resources

7.3 Awareness

7.4 Communication

7.5 Documented information

7.2 Competence

7.1.4 Environment for the

operation of processes

7.1.5 Monitoring and

measuring resources

7.1.2 People

7.1.3 Infrastructure

7.1.6 Organizational

knowledge

Clause 7.1

There should be adequate resources to ensure effectiveness of the QMS. Resource considerations now include:

internal resources

external providers

people

monitoring and measuring resources

organizational knowledge required to ensure the processes provide conforming products and services

external communication

.

7 Support

7.1 Resources

7.3 Awareness

7.4 Communication

7.5 Documented information

7.2 Competence

7.1.4 Environment for the

operation of processes

7.1.5 Monitoring and

measuring resources

7.1.2 People

7.1.3 Infrastructure

7.1.6 Organizational

knowledge

Clause 7.3 and 7.4

Relevant persons doing work under the organization’s control need to have awareness and communication (internal and external) of the QMS and benefits of improving performance

7 Support

Clause 7.5.1

Requirements that used to be required for a quality manual have been enhanced and made more flexible to allow for the use of documented information needed for the quality management system

Clause 7.5.2

Enhanced requirement for the creation and updating of documented information, e.g. description, format & suitability

Clause 7.5.3

Control of documented information – now explicitly includes confidentiality, integrity and access

7 Support

7.1 Resources

7.3 Awareness

7.4 Communication

7.5 Documented information

7.2 Competence

7.1.4 Environment for

operation of processes

7.1.5 Monitoring and

measuring resources

7.1.2 People

7.1.3 Infrastructure

7.1.6 Organizational

knowledge

4 Context of

organization

5 Leadership

6 Planning

8 Operation

9 Performance

and Evaluation

10 Improvement

4.1 Understanding

context

4.2 Interested parties

4.3 Scope

4.4QMS

5.1 Leadership and

commitment

6.1 Actions to

address risks and opportunities

6.2 Objectives and

planning

9.1 Monitoring,

measurement, analysis and evaluation

5.3Organizational

roles, responsibilities and authorities

9.2Internal audit

9.3 Management

review

8.1 Operational

planning and control

5.2 Policy

6.3 Planning of

changes

9.1.2Customer

satisfaction

9.1.3 Analysis and

evaluation

See next slide

7 Support

7.1 Resources

7.3 Awareness

7.4 Communication

7.5 Documented information

7.2 Competence

7.1.4 Environment for

operation of processes

7.1.5 Monitoring and

measuring resources

7.1.2 People

7.1.3 Infrastructure

7.1.6 Organizational

knowledge

10.2 Nonconformity and corrective

action

10.3Continual

improvement

10.1General

8.1 Operational planning and control

8.3.6 Design and development changes

8.5.3 Property belonging to customers or external providers

8.5 Production and service provision

8.5.1 Control of production and service provision

8.5.2 Identification and traceability

8.5.6 Control of changes

8.7 Control of nonconforming process outputs

8.5.4 Preservation

8.5.5 Post-delivery activities

8.6 Release of products and services

8.2 Requirements for products and services

8.2.1 Customer communication

8.2.2 Determination of requirements related to products and services

8.2.3 Review of requirements related to products and services

8.3 Design and development of products and services

8.4 Control of externally provided processes, products and services

8.4.1 General

8.4.2 Type and extent of control

8.4.3 Information for external providers

8.3.1 General

8.3.2 Design and development planning

8.3.3 Design and development Inputs

8.3.4 Design and development controls

8.3.5 Design and development outputs

4 Context of

organization

5 Leadership

6 Planning

7 Support

8 Operation

9 Performance and

Evaluation

10 Improvement

8.2.4 Changes to requirements for products and services

Clause 8.1.b

explicit requirement for establishing criteria for processes

Clause 8.2.1

explicit considerations are now linked to: customer communications; customer property, and contingency actions

Clause 8.2.2

Determination of requirements; this requires a process and is explicit with regard to substantiating claims for products and services being offered

8.1 Operational planning and control

8.2 Requirements for products and services

8.2.1 Customer communication

8.2.2 Determination of requirements related to products and services

8.2.3 Review of requirements related to products and services

8 Operation

8.2.4 Changes to requirements for products and services

Clause 8.3

This section on design and development of products and services has substantively changed and simplified:

Clause 8.3.2

Design and development has been restructured to allow for a more process orientated approach

Involvement of customers and users as part of design planning to be considered

Clause 8.3.3

Design and development inputs – explicit requirements for internal and external resource needs, potential consequences of failure, level of control expected by customers

Clause 8.3.4

Design and development controls – new clause combining Reviews, Verification & Validation

8 Operation

8.3.6 Design and development changes

8.3 Design and development of products and services

8.3.1 General

8.3.2 Design and development planning

8.3.3 Design and development inputs

8.3.4 Design and development controls

8.3.5 Design and development outputs

Clause 8.4

The terms which previously referred to purchasing and ‘outsourcing’ is now ‘Control of externally provided processes, products and services’

Clause 8.4.1

Conditions are applied when controls are required for externally provided processes, products and service

Terminology has changed from ‘supplier’ to ‘external provider’

Clause 8.4.2

Type and extent of control of external provision previous notes in 4.1 (ISO 9001:2008) now turned into requirements

Clause 8.4.3

Information for external providers are now more detailed and explicit

8.4 Control of externally provided processes products and services

8.4.1 General

8.4.2 Type and extent of control

8.4.3 Information for external providers

8 Operation

Clause 8.5.1

This clause specifically considers:

monitoring and measurement activities will ensure the control of processes and output (clauses 8.2.3 and 8.2.4 of ISO 9001:2008 have been moved to 8.5.1)

acceptance criteria for products and services are met

the use, and control of suitable infrastructure and process environment

suitable monitoring and measuring resources

Requires competent persons

8.5.3 Property belonging to customers or external providers

8.5 Production and service provision

8.5.1 Control of production and service provision

8.5.2 Identification and traceability

8.5.6 Control of changes

8.5.4 Preservation

8.5.5 Post-delivery activities

8 Operation

Clause 8.5.2

The identification and traceability now focus on ‘outputs’ rather than on ‘product’ (includes intermediate products and services) rather than on ‘product’

Clause 8.5.3

Customer property has been expanded to include external providers’ property

Clause 8.5.4

Preservation of product has been changed to preservation of the output

Clause 8.5.5

Post-delivery activities is a new clause

Clause 8.5.6

A new requirement for the control of changes is addressed in the slide introducing the concept of change

8.5 Production and service provision

8.5.1 Control of production and service provision

8.5.2 Identification and traceability

8.5.6 Control of changes

8.5.5 Post-delivery activities

8.5.3 Property belonging to customers or external providers

8.5.4 Preservation

8 Operation

Clause 8.6

The release of products and services is now part of the operational requirements

Clause 8.7

The control of nonconforming output is more explicit; it now considers the options to apply correction and corrective action

Nonconforming product changed to nonconforming output

8.6 Release of products and services

8.7 Control of nonconforming outputs

8 Operation

4 Context of

organization

5 Leadership

6 Planning

8 Operation

9 Performance

evaluation

10 Improvement

4.1 Understanding

context

4.2 Interested parties

4.3 Scope

4.4QMS

5.1 Leadership and

commitment

6.1 Actions to

address risks and opportunities

6.2 Quality objectives

and planning

9.1 Monitoring,

measurement, analysis and evaluation

5.3Organizational

roles, responsibilities and authorities

9.2Internal audit

9.3 Management

review

8.1 Operational

planning and control

5.2 Policy

6.3 Planning of

changes

9.1.2Customer

satisfaction

9.1.3 Analysis and

evaluation

See next slide

7 Support

7.1 Resources

7.3 Awareness

7.4 Communication

7.5 Documented information

7.2 Competence

7.1.4 Environment for the

operation of processes

7.1.5 Monitoring and

measuring resources

7.1.2 People

7.1.3 Infrastructure

7.1.6 Organizational

knowledge

10.2 Nonconformity and corrective

action

10.3Continual

improvement

10.1General

Clause 9.1.1

In 8.1 ISO 9001:2008 (clause 8.1) there was a requirement for planning. This is replaced with identifying what needs monitoring and measuring, and the methods to be used

Clause 9.1.3

There are specific requirements for analysis and evaluation when using results as inputs to management review

Effective implementation of planning and actions to address risks and opportunities are new requirements in this clause

9 Performance

evaluation

9.2Internal audit

9.3 Management review

9.1.2Customer satisfaction

9.1.3 Analysis and evaluation

9.1.1 General

9.1 Monitoring,

measurement, analysis and evaluation

Clause 9.2 Internal audit program now has explicit considerations for:

quality objectives, customer feedback and changes impacting the organization; management responsibility for action is now implicit whereas previously this was explicit

An auditor is now required to be impartial versus in the previous version they could not audit their own work

Clause 9.3 There are now additional requirements for management

review. These include:

changes in external and internal issues (such as strategic direction)

performance concerning external providers

adequacy of resources for effective QMS and effectiveness of actions taken addressing risks & opportunities

Clause 9.3.1 Management reviews should be aligned to the strategic

direction of the organization

Clause 9.3.3 Management review outputs have been enhanced to include

many of the new areas of focus

9 Performance Evaluation

9.1 Monitoring,

measurement, analysis and evaluation

9.2Internal audit

9.3 Management review

9.1.2Customer satisfaction

9.1.3 Analysis and evaluation

9.3.1 General

9.3.3 Management review

output

9.3 .2Management review

input

4 Context of

organization

5 Leadership

6 Planning

8 Operation

9 Performance Evaluation

10 Improvement

4.1 Understanding

context

4.2 Interested parties

4.3 Scope

4.4QMS

5.1 Leadership and

commitment

6.1 Actions to

address risks and opportunities

6.2 Objectives and

planning

9.1 Monitoring,

measurement, analysis and evaluation

10.1 General

10.2 Nonconformity and corrective

action5.3

Organizational roles,

responsibilities and authorities

9.2Internal audit

9.3 Management

review

8.1 Operational

planning and control

5.2 Policy

6.3 Planning of

changes

9.1.2Customer

satisfaction

9.1.3 Analysis and

evaluation

See next slide

7 Support

7.1 Resources

7.3 Awareness

7.4 Communication

7.5 Documented information

7.2 Competence

7.1.4 Environment for the

operation of processes

7.1.5 Monitoring and

measuring resources

7.1.2 People

7.1.3 Infrastructure

7.1.6 Organizational

knowledge

10.3Continual

improvement

Clause 10.1 This clause is new, it addresses more comprehensive

opportunities for improvement; not only continual improvement Addresses improvement of products and services and future

needs and expectations Emphasis is now on improving processes to prevent

nonconformities and improving products and servicesClause 10.2 The nonconformity referred to in this clause concerns the entire

QMS and not specifically the products or services which are addressed under clause 8.7

Clause 10.2.1 New emphasis is placed on nonconformity and corrective action Consequences are now included thus actions taken now

recognize the potential occurrence of a similar nonconformity elsewhere

Risks and opportunities now need to be updated when required following a nonconformity

Clause 10.2.2 Documented information is now required on the nature of the

nonconformity and subsequent actions takenClause 10.3 Opportunities shall be addressed as part of continual

improvement

10 Improvement

10.2 Nonconformity and corrective action

10.3 Continual improvement

10.1 General

Summary Determining the organizational context enables a more effective

implementation of the quality management system

Greater emphasis on processes being managed to achieve

planned results

Alignment with strategic direction

Integration of the QMS into organization’s business processes

Determining risks and opportunities increase the effectiveness

of the organization’s QMS

Change management has been expanded to add emphasis that

the QMS should be carried out in a planned manner

The concept of organizational knowledge introduced to ensure

the organization acquires and maintains the necessary

knowledge

Communication expanded to include external

ISO 9001:2015 CertificationTransition Timeline

September 2015 start of 3 years transition period to September 2018Certifications to ISO 9001:2008 will no longer be valid after September 2018

2018201720162015

September 2015

Published International Standard

Brad Fischer

SD Manufacturing & Technology Solutions

605-202-9118

[email protected]

www.sdmanufacturing.com

Contact Information